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Silo Pharma Announces Successful Production of its SP-26 Ketamine Implant for Fibromyalgia
Analytical testing has confirmed optimal formulation for upcoming studies SARASOTA, FL, June 07, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO)
About this update from Silo Pharma, Inc.
[{"type":"text","content":"Analytical testing has confirmed optimal formulation for upcoming studies SARASOTA, FL, June 07, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced a successful series of development activities for the Company’s SP-26 ketamine implant therapeutic targeting fibromyalgia and chronic pain. An ongoing pre-clinical research study of SP-26 is underway involving analytical testing services and small batch proof-of-concept extrusion trials for the ketamine hydrochloride (ketamine HCL) implants at 20% and 40% drug load. The Company previously reported that the initial testing provided validation of the delivery system based on measures of structural stability and integrity at both load levels. Following those tests, a series of manufacturing studies were conducted using three different bioresorbable polymers. The assay testing revealed positive data for inherent viscosity (IV), blend uniformity (BU), and dissolution of the implants: IV results were within the expected range for drug delivery of the active ingredient, and higher for the combined formulation with ketamineThe sample results met FDA guidelines for an adequate level of blendingThe larger implants showed faster dissolution time Silo CEO, Eric Weisblum commented, “The results so far in our ongoing SP-26 pre-clinical research bring us closer to determining the optimal formulation for future pre-clinical testing models. We are pleased with the structural stability, integrity, and functionality observed to date for our innovative non-opioid chronic pain therapeutic.” About SP-26 Silo’s SP-26 is a ketamine-based injectable dissolvable implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.About Silo Pharma Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, a...